PMA P160017S108

Device: MiniMed 670G System
Applicant: Medtronic Minimed, Inc.
PMA number: P160017
Supplement: S108
Product code: OZP
Decision date: 2023-04-18
Classification: Clinical Chemistry
Generic name: Automated insulin dosing device system, single hormonal control
Approval order statement: Approval for a minor design change to the Next Generation Pumps (NGP) to remove remote bolus functionality, remove remote settings modification, and disable over the air programming. The proposed changes address vulnerabilities in connection with Field Action (FA1272) and will be implemented in the MiniMed 670G and 630G Insulin Pumps.

Current openFDA PMA Record#

Device: MiniMed 670G System
Applicant: Medtronic Minimed, Inc.
PMA number: P160017
Supplement: S108
Product code: OZP
Generic name: Automated insulin dosing device system, single hormonal control
Decision date: 2023-04-18
Decision code: APPR
Date received: 2023-01-26
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: Approval for a minor design change to the Next Generation Pumps (NGP) to remove remote bolus functionality, remove remote settings modification, and disable over the air programming. The proposed changes address vulnerabilities in connection with Field Action (FA1272) and will be implemented in the MiniMed 670G and 630G Insulin Pumps.